Senior Calibration Specialist

4 days ago


Raleigh, North Carolina, United States SEC Life Sciences Full time
Senior Calibration Technician Role

We are seeking a highly skilled Senior Calibration Technician to join our team at SEC Life Sciences in Research Triangle Park, North Carolina. As a key member of our laboratory operations team, you will play a critical role in ensuring the optimal performance of our cutting-edge laboratory equipment.

Key Responsibilities:
  • Plan and execute calibration, maintenance, and repairs on laboratory equipment, utilizing our Computerized Maintenance Management System (CMMS).
  • Oversee and manage on-site vendors, ensuring they meet all training and compliance standards for equipment servicing.
  • Conduct detailed reviews and approvals of calibration and maintenance documentation from external vendors, focusing on good documentation practices.
  • Lead investigations related to equipment calibration failures and other technical issues, ensuring swift resolution.
  • Assist in the induction of new equipment by developing calibration schedules and requirements in collaboration with equipment owners.
  • Research operating specifications of new equipment and develop appropriate calibration standards and acceptance criteria.
  • Perform thermal mapping studies for controlled environments to validate and enhance equipment performance.
  • Generate and maintain Standard Operating Procedures (SOPs) related to the operation, maintenance, and calibration of lab instrumentation.
  • Interface with multidisciplinary teams including Quality Assurance, IT, Facilities, and Engineering to ensure seamless equipment operation.
  • Thoroughly document all activities within the CMMS to ensure data integrity and compliance.
  • Ensure compliance with industry regulations, including USP, NIST, FDA, GLP, and GMP, during all calibration and mapping activities.
Requirements:
  • 8-10 years of metrology experience, or a Bachelor's Degree and 5+ years of relevant experience.
  • Experience working within the Pharma or Biotech industries.
  • Strong understanding of calibration methodology, including loop calibrations and tolerances.
  • In-depth knowledge of FDA and GxP regulations, with hands-on experience in GMP and GLP environments.
  • Familiarity with CAPA investigations and deviation management.
  • Ability to read and interpret technical drawings for instrumentation.
  • Proficient in working with laboratory analytical instrumentation and small-scale manufacturing equipment.
  • Excellent communication and organizational skills, with the ability to work independently in a fast-paced environment.
Preferred Qualifications:
  • Bachelor's Degree in a relevant field.
  • Certified Calibration Technician (CCT).
  • Experience working in CLIA and R&D laboratory environments.


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